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Toxicological information

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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Two reliable in vitro genetic toxicity studies are available. In an Ames test performed according to OECD guideline 471 (BioReliance, 2010) the test substance demonstrated to be negative for mutagenicity with and without metabolic activation in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and E. coli strain WP2 uvr A.
In a CHO/HGPRT assay performed according to OECD guideline 476 (BioReliance, 2010), the test substance demonstrated negative for mutagenicity with and without metabolic activation. No toxicity was observed. No in vitro cytogenicity / chromosome aberration study in mammalian cells was performed as adequate in vivo data is available.


Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

In an in vivo micronucleus test on mouse bone marrow erythrocytes (BioReliance, 2010), performed according to OECD guideline 474, the animals were exposed orally (via gavage) with 500, 1000, 2000 mg/kg. This did not induce a statistically positive increase in micronuclei in the hemopoietic cells of the mouse bone marrow at the time intervals evaluated under the experimental condition of this assay. No toxicity was observed. Vehicle and positive controls were valid.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Genetic toxicity in vitro:

In a bacterial reverse mutation assay performed according to OECD guideline 471 (Ames; BioReliance, 2011; Klimisch 1), the mutagenic potential of the test substance was investigated in Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and E coli WP2 uvrA. Under the test conditions, the test substance demonstrated to be not mutagenic with and without metabolic activation. Toxicity or precipitation was not observed.

The test substance was tested in an in vitro mammalian cell gene mutation test (CHO/HGPRT test), performed according to OECD guideline 476 (Bioreliance, 2011; Klimisch 1). Under the conditions of the test, the test substance demonstrated to be negative with and without metabolic activation in the assay. Cloning efficiency was not effected by the substance as no cytotoxicity was observed.

According to the REACH Regulation, no in vitro cytogenicity study in mammalian cells or in vitro micronucleus study needs to be conducted if adequate data from an in vivo cytogenicity test are available (Annex VIII, Column 2 adaptation).

Genetic toxicity in vivo:

In an in vivo micronucleus test on mouse bone marrow erythrocytes, performed according to the OECD guideline 474 (Bioreliance, 2011; Klimisch 2), the animals were exposed orally (via gavage) with 500, 1000 or 2000 mg/kg test item. This did not induce a statistically positive increase in micronuclei in the hemopoietic cells of the mouse bone marrow at the time intervals evaluated under the experimental condition of this assay. No toxicity was observed. Vehicle and positive controls were valid.

Justification for classification or non-classification

Based on the available data and according to the CLP criteria, the test substance should not be classified as mutagenic or clastogenic.